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Report describes potential problem with new drug for seizures, pain

relief of her chronic pain, the woman suddenly stopped taking pregabalin when the FDA temporarily halted all trials. The next day she developed nausea, headache and dizziness symptoms at first attributed to the flu. A week later, however, she developed hallucinations, distorted color perception and difficulty reading, symptoms she found terrifying. Over subsequent weeks, the symptoms improved, but the woman still feels that she has never fully recovered.

MR imaging studies of the patient's brain taken three weeks after the onset of symptoms showed an area of edema fluid buildup in a part of the brain called the corpus callosum. Similar lesions have been seen in MR images of patients with epilepsy who had abruptly discontinued use of other AEDs, but those changes had been attributed to the seizures. "The fact that our patient had never had seizures suggests that suddenly stopping these medications could be enough to cause these problems," says Oaklander. "Also, in the past these MRI changes have been considered not to cause illness. Now that we know the kind of symptoms that they may produce, doctors will be able to look more carefully at other patients with these changes to see if they also became ill."

The researchers also noted that this patient's symptoms and MRI changes were similar to those that occur in severe high-altitude sickness. There are good treatments for high-altitude associated edema, so the authors suggest that those therapies be considered for any other patients who develop symptoms after suddenly stopping AEDs.

Pregabalin is very similar to gabapentin (Neurontin), an antiepileptic drug already in wide use for various conditions. Although it is not yet on the market, pregabalin has now received preliminary FDA approval to treat neuropathic pain and seizure disorders, and it is expected to be widely prescribed.

"As far as I know, no one has prospectively studied the risk of complications from withdrawal
'"/>

Contact: Sue McGreevey
smcgreevey@partners.org
617-724-2764
Massachusetts General Hospital
6-Jul-2005


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